FDA Approval Process

The FDA approval process ensures that new drugs and medical devices are safe and effective. It begins with laboratory and animal testing, followed by clinical trials involving human volunteers. These trials are conducted in three phases, gradually expanding the number of participants to gather comprehensive data on effectiveness and side effects. After trials, the manufacturer submits results to the FDA for review. If the FDA finds the evidence satisfactory, they grant approval for public use. Ongoing monitoring continues after approval to ensure safety and efficacy in the general population.